Surveillance Regulatory Affairs Officer

Responsible for activities related to the Company’s regulatory management systems, including coordinating, training, developing, improving, and implementing existing and new regulatory pathways. - Prepares, submits, tracks, indexes and archives electronic submissions including information, amendments, annual reports, general correspondence, adverse event...

**Get to know our Team**: For more than 10 years, we have been dedicated to creating a substance-free safe working environment for our customers. Alcotech was established in 2012 and is a company that specialises in Drug and Alcohol Testing. We operate a global network of specimen collectors to help our customers conduct drug and alcohol testing worldwide....

**Job Description - Regulatory Affairs Executive** - Ensure compliance with applicable regulatory requirements and standards for medical device. - Assist in the drafting, compiling and maintaining of technical documents to ensure compliance to the applicable domestic and international regulations and standards. - Prepare and submit regulatory technical...

**Role & Responsibility**: - The role of Regulatory Affairs Officer focuses on coordinating and documenting regulatory processes, such as inspections, license renewals, or registrations; compiling and preparing materials for submission to regulatory agencies related to regulatory initiatives; - Maintaining regulatory compliance of products for the following...

**Headquartered: US**: - **Position: Regional**: - **Product Porfolio: Medical Devices**: - **Reporting to: Regulatory Affairs Manager** **MAIN RESPONSIBILITIES**: - Facilitate regulatory affairs activities related to regulatory submissions, annual reports, registrations, and listings while ensuring compliance with relevant medical device regulations,...

Alcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia. Role Overview We are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences...

AVP / VP of Regulatory and Quality Affairs Overview AVP / VP of Regulatory and Quality Affairs role focusing on regulatory and quality strategy for APAC with responsibilities spanning regulatory submissions, quality management, and cross-functional leadership within medical device software/manufacturing context. Responsibilities Develop and execute the APAC...

**_*Fresh Graduates are welcome!* - ** **Responsibilities**: - Responsible for regulatory activities and quality assurance in SE Asia - Timely coordination and submission of product registration and follow up request i.e. new products, license renewals and product amendments. This would include product grouping and risk classification, and regular update...

Responsibilities Strategic Leadership & Planning (a) Develop and execute the APAC regulatory and quality affairs strategy aligned with business objectives and market expansion goals. (b) Define and drive the regulatory pathway strategy for product portfolios to optimize time‑to‑market and competitive positioning. (c) Support data privacy and information...

**THE OPPORTUNITY**: An esteemed **Medical Devices Company **is currently seeking a highly capable **Regulatory Affairs Specialist **to join their team. The successful incumbent will be tasked with the development and implementation of efficient regulatory strategies and processes, ensuring timely product registration, life cycle management, and post-market...